Trial Outcomes & Findings for Endoscopic Mucosal Resection and Cellular Matrix (NCT NCT03240679)
NCT ID: NCT03240679
Last Updated: 2023-02-06
Results Overview
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
approximately 3-4 months post EMR
Results posted on
2023-02-06
Participant Flow
Participant milestones
| Measure |
Endoscopic Submucosal Resection With Extracelluar Matrix
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
|
Endoscopic Submucosal Resection Standard of Care
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endoscopic Submucosal Resection With Extracelluar Matrix
n=1 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
|
Endoscopic Submucosal Resection Standard of Care
n=2 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: approximately 3-4 months post EMRNumber of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
Outcome measures
| Measure |
Endoscopic Submucosal Resection With Extracelluar Matrix
n=1 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
|
Endoscopic Submucosal Resection Standard of Care
n=2 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
|
|---|---|---|
|
Completeness of EMR Site Healing at Follow up Endoscopy
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: approximately 3-4 months post EMRNumber of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).
Outcome measures
| Measure |
Endoscopic Submucosal Resection With Extracelluar Matrix
n=1 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
|
Endoscopic Submucosal Resection Standard of Care
n=2 Participants
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
|
|---|---|---|
|
Presence of Stricture Formation at Follow up Endoscopy
|
0 Participants
|
0 Participants
|
Adverse Events
Endoscopic Submucosal Resection With Extracelluar Matrix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endoscopic Submucosal Resection Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place